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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name x-ray, tomography, computed, dental
510(k) Number K120948
Device Name PREXION 3D
Applicant
THE YOSHIDA DENTAL MFG. CO., LTD.
1-3-6 KOTOBASHI, SUMIDA-KU
TOKYO,  JP 130-8516
Applicant Contact HIDENORI WATANABE
Correspondent
THE YOSHIDA DENTAL MFG. CO., LTD.
1-3-6 KOTOBASHI, SUMIDA-KU
TOKYO,  JP 130-8516
Correspondent Contact HIDENORI WATANABE
Regulation Number892.1750
Classification Product Code
OAS  
Date Received03/29/2012
Decision Date 12/21/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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